Trial Outcomes

Doing clinical trials is very exciting and rewarding work! However, in some ways, it’s like working in an Emergency Department. You see one early snapshot of something, but you frequently don’t know the eventual outcome. It can be an interesting and harrowing journey, with roadblocks, detours, bottlenecks, construction messes and accidents.

Hopefully, we reach our destinations!

Some of the obvious results: some drugs are discontinued in early phases of development, when they are just letters and numbers; some drugs make it long enough to have a generic name; some even get to the point of a brand name. Once trial results are submitted to the FDA, the drug is typically either approved or not approved. Once approved, a drug may continue in the marketplace or be discontinued. We’ve seen it all!

What is surprising is how often trials are discontinued. This is for a variety of reasons. The drug may not work; the drug may have too many side effects; placebo may have a more positive outcome; the FDA may require elaborate further testing that is not feasible financially; the overall cost of producing the drug may not warrant the eventual profit; and issues in the news and subsequent climate surrounding an issue may nullify potential benefits of a product (e.g. the current opioid epidemic for a company with a new sustained release opiate).

Even more surprising is how often a drug is approved and marketed and then subsequently removed from the market. This is usually because of negative consumer experiences, which are reported to the FDA.

Overall, though, we have numerous wonderful medications that improve quality of life and save lives. This is thanks to the amazing work of our researchers, clinical research coordinators, and extremely important volunteers in our clinical trials!